Kornimate/medical-research-clean huggingface dataset:
assessment of coagulation profile and haematopoietic responses in patients with acute-on-chronic liver failure during systemic inflammatory response (sirs) and sepsis

Conditions: Acute on Chronic Liver Failure

Summary: this study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. further research is needed for proper understanding of the influence of sepsis on coagulation disorders in aclf (acute on chronic liver failure) patients in particular, to correctly identify the type and optimal quantity of blood product requirement in at risk patients. thromboelastography (teg) /sonoclot have been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. in the present study, patients with aclf (acute on chronic liver failure) without evidence of sepsis on admission will be included in the study cohort, and will undergo a baseline diagnostic workup as described. they will be followed for development of any signs of infection after hospitalization. then the effect of sepsis on their coagulation and haematopoietic cellular responses will be assessed. thus the effect of sepsis on the progression and outcome of patients with aclf (acute on chronic liver failure) will be studied.


Eligibility criteria:
inclusion criteria: * age 18-65 years * aclf (acute on chronic liver failure), as diagnosed by apasl (asian pacific association of study of liver disease) criteria mentioned above. exclusion criteria: * patients with evidence of sepsis at presentation. * current therapy: recent blood or blood component transfusion in the last 2 days. * hiv positive/ aids patients * patients requiring anti platelet therapy, * renal insufficiency requiring dialysis * active malignancy within the last 5 years * patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease * administration of anticoagulants, antifibrinolytics, * not willing to participate in the study * pregnancy
diagnostic trial to validate the use of the e-nose in pulmonary tb

Conditions: Tuberculosis, Pulmonary; e-Nose

Summary: determine the diagnostic accuracy for pulmonary tuberculosis in adults of the e-nose in venezuela.

acronyms: tuberculosis (tb) receiver operating curve (roc) common terminology criteria for adverse effects (ctcae) the aim of the study is to determine the diagnostic utility of the device 'electronic nose' for pulmonary tuberculosis. prospective, open, three - arm controlled trial study. validation of the e-nose in urban settings to estimate the diagnostic accuracy of the e-nose using exhaled air in patients with pulmonary tb in adults. the patients who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in netherlands. during and after the use of the device, we determine the adverse effects of the intervention, according to the ctcea. the researchers use the sputum culture, which is the gold standard, to determine the diagnostic utility of the test. and, will compare the results with other tests currently perform as the regular diagnostic routine, such as chest x-ray, sputum smear, and symptom based diagnosis. the patients in the experimental group are invited to come during the treatment phase, and will be asses the progress of the treatment, as well as another use of the device, at 5, 15, 30, 60 days after initiation of treatment, and will be compared the results of the device, with symptoms, x-ray changes, improvement of anthropometric findings, to determine the utility of the device to measure the response to treatment. patient registries will be keep in an electronic database, as well as handwriting history, with the backup copy in the records of the hospital in which the patient was admitted. auditoriae will be realised by the ethics comite in different time frames.

Eligibility criteria:
inclusion criteria: * accept to participate in the study through a signed informed consent approved by the ethical committee of our institution. * more than 15 years old. * people with a culture positive for pulmonary tb exclusion criteria: * severe compromise of the general condition. * not capable to exhaled through the e-nose. * no possibility to follow-up. * by discretion of the research team.
reconstitution of hiv-specific immunity against hiv

Conditions: HIV

Summary: research goal: to reconstitute the anti-hiv specific immunity system of the aids patients, so the viruses could not massively replicate when haart was discontinued, then make hiv functional cure possible.

the research aims at establishing a new treatment strategies of hiv. it will significantly improve the clinical therapy effects and effectively reduce the morbidity and mortality by reconstituting the immune systems of hiv infected patients and combining multiple therapy strategies. therefore, the research could develop an cloning amplification system of immunocytes in vitro, and improve the antiviral immune system severely damaged before by transfusing the clone cells modified by specific hiv antigen. so hiv infected patients could discontinue the traditional anti-viral drug, but not develop opportunistic infections,which could obviously increase the life qualities of these patients.

Eligibility criteria:
inclusion criteria: 1. hiv infection confirmed 2. receiving haart more than 6 months 3. hiv viral-load \< 50 copies/ml 4. without serious damage of liver and kidney 5. the subject volunteered to the research and sign the informed consent exclusion criteria: 1. with serious opportunistic infections 2. with serious chronic disease such like diabetes, the mental illness,et al 3. history of suffering from pancreatitis during haart. 4. pregnant and breast-fed. 5. with poor adherence

Keywords: hiv cellular immunity therapy functional cure
black health identification program (b-hip)

Conditions: Multiple Chronic Conditions; Family Members

Summary: nearly 69% of african american (aa) medicare beneficiaries have multiple chronic conditions (mccs) such as cancer and cardiopulmonary diseases. older age and mccs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding treatment decision-making. studies have shown that early palliative care participation achieves beneficial goals of care communication, quality of life (qol), symptom burden, and mood in older adults with cancer and heart failure as well as among their family caregivers. however, older aas with mccs, especially those living in the deep south, are less likely to have access to early palliative care, even though they generally experience higher symptom burden, healthcare use, and poorer communication around goals of care. this disparity in palliative care use may be, in part, to a lack of culturally-responsive care practices that effectively activate aas with mccs to identify their own values and priorities for end-of-life care. while efficacious communication models exist, few have been tested in culturally-diverse samples. guided by the theory of social cognitive theory and health behavior model, this study's purpose is to conduct a formative evaluation of a self-directed "my health priorities" identification program to determine cultural acceptability and feasibility of use in among aas with mccs in a primary care setting. the 2-phase study specific aims are to: aim 1. (phase 1) conduct a single-arm formative evaluation trial of self-directed "my health priorities" identification program to determine acceptability and feasibility with a sample of 20 aa patients with mccs and fcgs and adapt for future efficacy testing. aim 2. (phase 2) to examine the ability of the dyads to complete pre- and post-test measures of perception of care, treatment burden, shared decision-making, and communication exchange. the findings from the research will directly inform a small-scale pilot grant that will assess acceptability, feasibility, and potential efficacy of a values solicitation and operationalization intervention for aas with mccs and caregivers.


Eligibility criteria:
inclusion criteria for patients * african american (aa) * ≥ 65 years * has at least two of the following chronic conditions: cancer, heart disease, kidney disease, liver disease * english-speaking * cognitively able to participate in decision-making discussions * reliable internet and telephone access * fcg willing to participate in study inclusion criteria for fcg * aa * 18 years * identified by patient as his/her primary fcg * english-speaking; and 5) reliable internet and telephone access. exclusion criteria for patients and fcg * axis i psychiatric disorder (schizophrenia, bipolar disorder), dementia * active substance use disorder * living in a nursing home or assisted living facility residence.
study to test whether pf-00547659 is safe and improves disease symptoms in patients with crohn's disease

Conditions: Crohn's Disease

Summary: adults with crohn's disease that is clinically active despite conventional treatment will be eligible for this study. patients may receive one of three doses of pf-00547659 (experimental drug) or placebo (inactive drug). disease activity will be measured every two weeks.


Eligibility criteria:
inclusion criteria: * subjects must have failed or are intolerant to anti-tnfs and/or immunosuppressants (aza, 6-mp, and/or mtx). * hscrp greater than 3mg/l * ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening exclusion criteria: * pregnant or breast feeding * short bowel syndrome due to multiple small bowel resections * presence of a stoma

Keywords: crohn's disease safety efficacy pharmacokinetics pharmacodynamics crohn's disease activity index (cdai)
a trial of mitoq for the treatment of people with parkinson's disease

Conditions: Parkinson's Disease

Summary: in parkinson's disease, the mitochondrial membranes in cells that produce dopamine become damaged by oxidants, leading to the death of these cells and progressive tremor, slowness of movement and the loss of neurons in the substantia nigra (a part of the brain that is involved in movement). mitoquinone is targeted to reach the membrane of mitochondria and provide protection from damaging oxidants. there are no treatments currently available to slow the progression of pd and this trial will help advance the development of this unique disease modifying drug. this trial will enroll 120 participants with untreated early onset of pd. participants will be randomized to receive 1 of 3 treatments: 40 mg of mitoq tablets, 80 mg of mitoq tablets or placebo. the researchers, participants and sponsor will all be blinded to the treatment allocation. participants will be assessed after 1, 2, 3, 6, 9, 12 months of treatment and again 28 days after their last dose. the effectiveness of the trial drug will be measured via the unified parkinson's disease rating scale (updrs). the safety of the trial drug will be monitored via regular participant examinations, blood tests, ecg and collecting information on adverse events.


Eligibility criteria:
inclusion criteria: 1. informed consent 2. 30 yrs or older 3. diagnosis of pd (2 or more of bradykinesia; rest tremor, rigidity) 4. adequate contraceptive measures (females) exclusion criteria: 1. malignancy within last 2 years 2. pregnancy \& breast-feeding 3. treatment with any anti-pd drugs within 30 days of enrolment 4. prior treatment with anti-pd medication exceeding 42 days in total 5. medication-induced pd/pd not of idiopathic origin 6. coq10/idebenone doses of 300mg/day or higher within 120 days, \>25mg/day within 7 days of enrolment 7. methylphenidate hcl, neuroleptics, reserpine, amphetamines, selegeline or maois within 6 months of enrolment 8. cns medications at unstable doses within 60 days of enrolment 9. dietary supplements \> 5 x rdi 10. hypersensitivity to coq10, idebenone or any components of the study drug 11. unable to swallow 12. diseases with features of pd 13. seizure(s) within 12 months prior to enrolment 14. updrs tremor score of 4 15. hamilton depression rating scale score \> 10 16. history of stroke 17. requirement for dopaminergic drugs 18. modified hoehn \& yahr score \> 2.5 19. history of brain surgery for parkinson's disease 20. history of structural brain disease / congenital brain abnormality 21. history of ect 22. any other clinically significant medical or psychiatric condition or lab abnormality 23. enrolment in any other pharmacological study within 30 days of enrolment

Keywords: parkinson's disease mitoq updrs
a study to evaluate mazdutide compared with placebo in participants with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (aud). for any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.


Eligibility criteria:
inclusion criteria: * current aud diagnosis as defined by diagnostic and statistical manual of mental disorders (dsm)-5 criteria. exclusion criteria: * have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months. * have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment. * have received any medication for aud in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate. * other protocol-specific inclusion and exclusion criteria may apply.
nails versus plates for femur fractures in dar es salaam, tanzania

Conditions: Femoral Fractures

Summary: this is a prospective observational study of patients with femur fractures in dar es salaam, tanzania comparing two different surgical techniques: intramedullary nailing (imn) and open reduction internal fixation (orif) with a plate. the primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. the investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an imn compared to orif with a plate.

the study will be a prospective clinical trial conducted at muhimbili orthopaedic institute (moi) in dar es salaam, tanzania. all adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. study subjects will be treated at the discretion of the surgeons at moi. this could include an intramedullary nail, a plate, external fixation, or skeletal traction. potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. the primary outcome considered will be reoperation for any reason. secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.

Eligibility criteria:
inclusion criteria: 1. diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate 2. age 18 to 65 exclusion criteria: 1. clinical evidence of infection at the surgical site (defined clinically as drainage or erythema) 2. pathologic fracture 3. prior surgery 4. presentation 3 weeks or more after injury 5. inability or unwillingness to comply with follow up to 1-year

Keywords: femur fracture internal fixation intramedullary nailing
a long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (itp).

Conditions: Primary Immune Thrombocytopenia

Summary: this is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of argx-113 in adult patients with primary itp.


Eligibility criteria:
inclusion criteria: 1. ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 2. patients enrolled in the argx-113-1801 trial who completed the 24-weeks trial period. 3. women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered. 4. women of childbearing potential should use a highly effective or acceptable method of contraception during the trial and for 90 days after the last administration of the imp. they must be on a stable regimen, for at least 1 month (as listed in the protocol) 6. ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 7. patient has completed a 52-week treatment period. exclusion criteria: 1. introduction or continuation of non-permitted medications during the argx-113-1801 trial (such as anti-cd20 therapy, romiplostim, monoclonal antibodies, fc fusion proteins or live/live-attenuated vaccines). 2. pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. 3. patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod. 4. use of any other investigational drug or participation in any other investigational trial.
topotecan in treating patients with recurrent or refractory cancer of the uterus

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of topotecan in treating patients with recurrent or refractory cancer of the uterus.

objectives: i. estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. ii. determine the nature and degree of toxic effects of topotecan in these patients. outline: patients receive topotecan iv over 30 minutes daily for 5 days. treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. patients with complete response, partial response, or stable disease continue treatment for at least three courses. patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death. projected accrual: approximately 25-40 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus measurable disease patient characteristics: age: not specified performance status: gog 0-2 life expectancy: not specified hematopoietic: platelet count at least 100,000/mm3 absolute granulocyte count at least 1,500/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 3 times uln alkaline phosphatase no greater than 3 times uln renal: creatinine no greater than 1.5 mg/dl creatinine clearance greater than 20 ml/min other: no invasive malignancies within the past 5 years except nonmelanomatous skin cancer no significant infection prior concurrent therapy: biologic therapy: at least 3 weeks since prior biologic therapy chemotherapy: at least 3 weeks since prior chemotherapy and recovered no prior topotecan or camptothecin therapy no more than 1 prior chemotherapy regimen (either single or combination chemotherapy) endocrine therapy: at least 3 weeks since prior endocrine therapy radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: prior surgery allowed and recovered

Keywords: recurrent uterine sarcoma uterine carcinosarcoma
a study of v260 in healthy chinese adults, children and infants (v260-028)(completed)

Conditions: Rotavirus Gastroenteritis

Summary: this study will assess the safety and tolerability of rotateq™ (v260) in the healthy chinese populations. approximately 144 participants will be enrolled and equally stratified into three age cohorts, cohort i ages 19-47 years, cohort ii ages 2-6 years, and cohort iii ages 6-12 weeks. randomization ratio is 1:1 in each cohort. the study will be conducted sequentially, participants in cohort i then cohort ii receiving 1 dose of, and then participants in cohort iii receiving 3 doses of rotateq™/placebo. the primary investigator and the ethics review committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. duration for the entire study will be approximately 6-9 months.


Eligibility criteria:
inclusion criteria: * healthy adults ages 19 to 47 years for cohort i * healthy children ages 2 to 6 years for cohort ii * healthy infants ages 6 to 12 weeks for cohort iii * negative pregnancy test for females in cohort i * signed informed consent forms (icfs) exclusion criteria: * participants in cohorts i and ii receiving any vaccine 14 days before or anticipated after study vaccine * participants in cohort iii receiving non-concomitant live vaccines 14 days before or after study vaccine * prior administration of any rotavirus vaccine * elevated temperature, with axillary temperature ≥37.1 degrees c 24 hours before study vaccine * prior or active gastrointestinal illnesses, immunodeficiency * any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant